TAG:
U.S. Supreme Court
Why Labs Should Comply with FDA’s Final Rule on LDTs
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
FDA Expected to Publish Proposed LDT Rule in August
CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which c…
CURRENT ISSUE
Volume XXXIII, No. 11 – September 2026
In the September 2026 briefing, The Dark Report digs into a CMS proposal to cut payments for CPT code 88305, potentially based on flawed thinking. Other coverage includes the evolving role of mass spectrometry in clinical labs, payer obstacles to blood-based biomarker tests for Alzheimer’s disease, and how young pathologists can get business skill help.
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